Impact of adding palatal rugae to complete dentures on patient satisfaction and oral health–related quality of life: A randomized crossover clinical trial

摘要

? 2020 Editorial Council for the Journal of Prosthetic DentistryStatement of problem: The addition of palatal rugae to complete dentures has been suggested to improve the satisfaction of patients with different oral functions. However, clinical studies to support these claims are lacking. Purpose: The purpose of this randomized, single-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures with palatal rugae compared with a polished palate. Material and methods: Edentulous patients aged 45 to 80 years, with no relevant medical conditions, seeking complete dentures at a university hospital between May and July 2019 were recruited. Each participant received new complete dentures. After a 1-week adaptation period, the participants were randomly allocated to 2 sequences through a computer-generated sequence. In the first sequence, palatal rugae were added to the complete dentures, and after 2 months, the palatal rugae were removed and the dentures used for another 2 months. In the second sequence, the opposite sequence was followed: polished palate first and palatal rugae second. After each period, a blinded dentist asked participants to rate their general satisfaction on a 100-mm visual analog scale (primary outcome) and to rate their satisfaction regarding eating, taste perception, speaking, phonetics, and ease of cleaning. Participants were also asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT). The paired sample t test and the Wilcoxon test were used (α=.05). Results: Fifty participants were randomized, of whom 6 dropped out. No significant differences were found between ratings for the 2 palatal contours in terms of general satisfaction 2.32 (95 confidence interval: -3.65 to 8.29, P=.438), eating 1.70 (95 confidence interval: -4.05 to 7.46, P=.554), taste perception 0.57 (95 confidence interval -5.04 to 6.17, P=.839), phonetics 1.48 (95 confidence interval -4.46 to 7.41, P=.618), or speaking 3.68 (95 confidence interval: -1.92 to 9.28, P=.192). However, satisfaction with ease of cleaning dentures with palatal rugae was significantly less 12.16 (95 confidence interval: 6.81 to 17.50, P.05), except for the frequency of mealtime interruption (P=.041), which was reported to increase when rugae had been provided. Conclusions: Complete dentures with palatal rugae were not perceived to improve patient satisfaction or oral health–related quality of life. However, they were perceived to be more difficult to clean and to increase frequency of interruptions during eating.